FDA 510(k) Application Details - K191593

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K191593
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Grandway Technology (Shenzhen) Limited no. 5, 2nd Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Patrick Chow Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2019
Decision Date	07/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review